Progesterone Micronized is indicated for

• the maintenance of pregnancy in cases of threatened or recurrent abortion.
• It is used for luteal support during IVF and ART procedures.
• It is indicated in cases of proven luteal phase insufficiency.
• It is used in secondary amenorrhea.
• It is indicated in dysfunctional uterine bleeding (DUB).

This preparation contains micronized progesterone which is structurally and biologically identical to natural endogenous progesterone. Progesterone is secreted by the ovary, placenta, and adrenal glands. In the presence of adequate estrogen, progesterone converts a proliferative endometrium into a secretory endometrium. Progesterone increases endometrial receptivity for embryo implantation. After implantation, progesterone helps maintain pregnancy. Progesterone administration reduces circulating gonadotropin levels.

Route of administration: Vaginal application

Maintenance of pregnancy in case of Threatened/Recurrent abortion: Use Progesterone Micronized vaginally once daily (90 mg of 8% gel).

Reproductive failure and in vitro fertilization treatment: Progesterone Micronized is given at a dose of 90 mg. Treatment is started within 4 days, preferably 2 days, after hCG (human chorionic gonadotropin) administration. One application of Progel 90 mg (8% gel) should be given vaginally daily or twice daily. Most women will respond to 90 mg given daily. However, some women may need 90 mg twice daily. If pregnancy occurs treatment may continue for up to 10 to 12 weeks.

Secondary Amenorrhea: Use Progesterone Micronized once a day (90 mg of 8% gel) for every alternative day for 6 days.

Use in children and adolescents: Progesterone Micronized is not indicated for use in children.

One application (applicator used to the ring mark) contains 1.125 gm of Progesterone Micronized, which contains 90 mg progesterone.

• Remove cap from the tube, invert it, and use the sharp point to open the tube.
• Pull the plunger up to the ring. Now attach it to the opening of the tube.
• Squeeze the tube slowly to the applicator up to the ring-mark (where the plunger stops).
• Remove the tube.
• To apply the Gel, lie down; insert the applicator deep into the vagina.
• Slowly push the plunger all the way in until the applicator is empty.
• After use, pull the plunger out of the barrel beyond the point of resistance and wash both parts in warm, soapy water. Do not use detergents. Rinse well and dry afterwards. Do not put the applicator in hot or boiling water.

Although no significant drug interactions have been reported, Progel is not recommended to be used together with other vaginal preparations.

It is contraindicated in known or suspected breast or genital organ malignancy.

It should not be used in missed abortion or undiagnosed uterine bleeding. It is contraindicated in liver dysfunction or liver disease. It should not be used in patients with hypersensitivity to any component of the formulation. It is contraindicated in progesterone-dependent neoplasia. It should not be used in active thrombophlebitis or thromboembolic disorders, cerebral apoplexy, or in patients with a history of hormone-related thromboembolic conditions. It is contraindicated in acute porphyria.

Common side effects include abdominal pain, perineal pain, constipation, nausea, diarrhea, vomiting, breast enlargement, dyspareunia, depression, decreased libido, nervousness, somnolence, intermenstrual spotting, and vaginal irritation.

Rare side effects include cerebrovascular disorders and pulmonary embolism.

Pregnancy category A. It has been used to support embryo implantation and maintain pregnancy successfully. It should not be used during lactation, as progestogens may pass into breast milk and the effect on the infant is not well established.

Discontinue immediately if cerebrovascular disorders, pulmonary embolism, or retinal thrombosis occurs. Stop treatment if liver function tests become abnormal or cholestatic jaundice develops. Patients with a history of depression should be closely monitored and the drug should be stopped if severe depression reappears. It should not be used with other vaginal therapies.

Acute overdose is unlikely due to limited vaginal absorption and sustained-release formulation. In case of overdose, Progel should be discontinued and symptomatic treatment should be given.

Drugs for infertility.

Store below 25°C in a dry place, protected from light. Keep all medicines out of the reach of children.